Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand...

Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of...

We often get questions from our customers about adherence to different industry standards. “Which ONE do you follow?” The answer is not as simple as it appears. In fact, the question itself is much more complex. Theories and standards of GAMP, ASTM E2500, ICH Q8, ICH...

Lean manufacturing is becoming prominent in the Life Sciences industry. The model has seen much success in a variety of other industries. This blog series will focus on revealing how Enterprise Asset Management (EAM) can drive lean. We will shed light on lean in the...

Now that I laid the framework for purpose-built EAM software and some core functionality requirements for regulated companies, I want to go into more detail about using EAM/CMMS features to manage compliance risks. There are two important factors to note surrounding...

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